The U.K.'s National Institute for Health and Care Excellence did not recommend Pfizer Inc.'s eczema therapy Staquis, citing uncertainties around the ointment's clinical effectiveness.
In draft guidance, the drug pricing watchdog said the effectiveness of Staquis, or crisaborole, as a second-line treatment for moderate atopic dermatitis was uncertain and the trial data submitted, which was based on an assessment tool used in the U.S., was unreliable, prone to bias and not used in the U.K.
The trial patient population did not accurately represent the proposed treatment group and the results were not generalizable to clinical practice in the U.K., NICE said Sept. 11.
In addition, there was no direct evidence comparing the treatment to topical calcineurin inhibitors tacrolimus and pimecrolimus, which are currently recommended by NICE as second-line therapy for the disease.
Staquis received EU authorization in March for people aged two years and older with up to 40% of their body affected by atopic dermatitis — a chronic skin condition that causes dry, cracked and itchy patches. The drug is marketed as Eucrisa in the U.S.